Additional Pharmacovigilance Study to Evaluate the Risks of Major Hemorrhage With the Administration of IMBRUVICA® (ibrutinib)

Study identification

• EU PAS number:
  EUPAS27376
• Study ID:
  27377
• Official title and acronym:
  Additional Pharmacovigilance Study to Evaluate the Risks of Major Hemorrhage With the Administration of IMBRUVICA® (ibrutinib)
• DARWIN EU® study:
  No
• Study countries:
  United States
• Study description:
  HaemorrhageSince for technical reasons haemorrhage is not in the MedDRA PT for selection and no more than 10 MedDRA Lower Level Terms (LLTs) can be selected, the most important terms from the available list of terms are provided (broader terms (PT or HLT) in that field,Cerebral, Subdural, and Subarachnoid hemorrhage
• Study status:
  Finalised

Research institutions and networks

Institutions

NA, retrospective database analysis

Study timelines

Date when funding contract was signed

Planned:28/01/2016

Actual:28/01/2016

Study start date

Planned:25/02/2009

Actual:03/10/2008

Date of final study report

Planned:12/12/2018

Actual:13/12/2018

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Janssen Research & Development

Regulatory

• Was the study required by a regulatory body?:
  Yes
• Is the study required by a Risk Management Plan (RMP)?:
  EU RMP category 3 (required)